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Bosulif Approved to Treat Newly-Diagnosed Ph+ CML

Avillion news release; 2017 Dec 19

The US Food and Drug Administration (FDA) has approved Bosulif (bosutinib) to treat adults with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

Indications: Bosulif is a kinase inhibitor indicated for the treatment of adult patients with newly-diagnosed chronic phase Ph+ CML.

Dosage and administration: 400 mg orally once daily with food.

Efficacy and safety: Approval is based on results of an open-label phase 3 study that showed Bosulif 400 mg was linked with a significantly higher rate of patients achieving major molecular response at 12 months vs the rate achieved with imatinib 400 mg (47% vs 37%). Complete cytogenic response was 77% and 66%, respectively.

Side effects/risks: The most common adverse reactions are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.


Avillion announces US Approval of Pfizer's Bosulif (bosutinib) for the treatment of patients with newly-diagnosed Ph+ chronic myelogenous leukemia (CML) [news release]. London: Avillion LLP. December 19, 2017. Accessed December 25, 2017.

Bosulif [package insert]. New York, NY: Pfizer Labs, 2017. Accessed December 25, 2017.